RecruitingPhase 2NCT05824728

Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis


Sponsor

Johns Hopkins University

Enrollment

30 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical/neurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a medication called AGB101 (a low dose of levetiracetam, a drug also used for epilepsy) can safely reduce hallucinations, delusions, and other psychotic symptoms in people with Parkinson's disease. **You may be eligible if...** - You are 40–85 years old and have been diagnosed with Parkinson's disease - You experience hallucinations, delusions, illusions, or a false sense of someone being present at least once a week - These symptoms have been happening for at least one month and started after your Parkinson's diagnosis - You have a partner or caregiver who spends at least 2 hours per week with you - You are on a stable Parkinson's medication regimen for at least 4 weeks - You are willing and able to have MRI scans **You may NOT be eligible if...** - You have severe kidney problems or are on dialysis - You have another brain condition such as Alzheimer's, Huntington's, or a seizure disorder - You have a pre-existing diagnosis of schizophrenia, bipolar disorder, or another psychotic disorder unrelated to Parkinson's - You have had deep brain stimulation surgery - You have taken anticonvulsant medications in the past month - You are currently pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAGB101

low-dose levetiracetam, 220 mg, extended release tablet


Locations(1)

Johns Hopkins

Baltimore, Maryland, United States

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NCT05824728


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